Electromyographic (EMG) on the Anaesthesia Monitor

Phase 4

Completed

• Conditions: Anaesthesia

• Registration Number: NCT01142635
• Lead Sponsor: Tampere University Hospital

Brief Summary

Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors to show misleadingly high values. The investigators want to investigate whether this EMG activity can be visually seen on the anaesthesia monitor.

Detailed Description

Patients are anaesthetized with target controlled infusion of propofol. To facilitate intubation, the patients are randomized to receive rocuronium either 0,6 mg/kg or 1,2 mg/kg. BIS, Entropy and the biosignal collected with the Entropy strip are collected on a computer. The visible biosignal on the anaesthesia monitor is recorded with a video camera. BIS, Entropy, biosignal and video clip of the anaesthesia monitor will be analyzed in detail.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Last Update Submitted: 2010-06-10
• Study First Posted: 2010-06-11
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• females giving informed consent
• age range 18-65 years
• elective surgery: gynaecological
• general anaesthesia
• ASA classification 1 or 2

Exclusion Criteria

• pregnancy
• body mass index > 30
• disease affecting CNS
• overuse of alcohol
• drug abuse
• unability to understand, read or use Finnish language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The behaviour of biosignal on the anaesthesia monitor	30 minutes	The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor

Secondary Outcome Measures

Name	Time	Method
The behaviour of depth of anaesthesia indexes (BIS, SE, RE) during intubation	30 min	Intubation-associated changes in the numerical values of BIS, SE, RE

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland